
Compleware Corp.
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CLINDATALINK VERSION 1.0 FOR SPIROMETRY is an FDA 510(k)-cleared medical device (K020004) manufactured by Compleware Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 2002. Regulation: 8.